MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNSPECIFIED KNEE PATELLA IMPLANT; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CEMENTED POLY/METAL/POLY

Catalog Number	UNKNOWN
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patella was loose 10 years post-op.Revision surgery was performed to remove and replace patella.No delay or injury reported.Back up available.
Additional Manufacturer Narrative
The wrong part number had been reported.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Therefore a product analysis could not be performed.After repeated requests, smith and nephew has been unable to obtain device details.Smith and nephew has an outstanding request with the reporter for information.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch information.Clinical evaluation noted that no clinical relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.The patient impact beyond the reported revisions cannot be determined.No further medical assessment is warranted at this time.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: UNSPECIFIED KNEE PATELLA IMPLANT
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CEMENTED POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8072041
• Report Number: 1020279-2018-02486
• Device Sequence Number: 1668607
• Product Code: JWH
• UDI-Device Identifier: 03596010559036
• UDI-Public: 03596010559036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018; 10/24/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 07/08/2019; 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention